This invention is directed to an apparatus and method for fully automated, noninvasive quality control of a substance in a closed system. More specifically, it relates to an apparatus and method for noninvasively measuring physical, chemical or optical properties of a substance, and comparing the measured values to end-use acceptable values for the substance.
Quality Control (hereinafter “QC”) devices and methods have become an increasingly important part of healthcare over the last few decades. Typically, QC devices utilize invasive methods such as testing with probes, and/or substance withdrawal techniques to assess whether the substance meets its threshold guidelines. However, invasive techniques like the ones employed in many QC apparati are not suitable for applications that require a substance to be part of an entirely closed and sterile system, or where substance loss is undesirable.
Furthermore, specifically in healthcare, QC has traditionally occurred at the site of the manufacturer, as opposed to the point of use. However, with the development of new contrast agents and other short half-life pharmaceutical products, it may be necessary to perform compounding or processing steps immediately prior to administration into the patient. Prior to injection, the safety and efficacy of the substance must be ensured. A fully automated noninvasive QC analysis at this point of use would serve as an insurance.
The use of some noninvasive techniques to gather information about a particular substance is well known in the art. For instance, the use of absorption spectroscopy to find the concentration of known solutions is well known. Additionally, infrared pyrometery has been used to noninvasively measure the temperature of a substance.
Difficulties arise when QC of a substance requires testing multiple variables in real-time, when full automation is necessary. By “real-time” is meant that the results of the QC are produced at substantially the same rate that the data is acquired.
Such a QC apparatus, for example, may be useful in medicinal applications in which an agent is administered directly to a patient, where it may be necessary to ensure the efficacy and safety of the pharmaceutical product being tested by acquiring, for instance, the pH, temperature, liquid-state polarization, concentration and/or volume of the agent while comparing those values to proper end-use values or threshold guidelines, all without the substance leaving a closed system. In addition, such a QC system may operate directly at a patient's bedside, potentially obviating the need of a bedside pharmacist.
Therefore, what is needed is a fully automated, noninvasive, closed system QC apparatus and method adapted to measure one or more properties of a substance in real-time, compare each property value to an appropriate end-use value, and if the substance meets the end-use value, a release mechanism configured to allow for the release of the substance to its end-use all while preserving the sterility of the substance being tested.